Is It Time For Hearing Aids To Be Sold Over The Counter?

Composer Richard Einhorn, who says paying for hearing aids was a struggle on a musician's income, supports efforts to gain FDA approval for cheaper devices.

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Originally published on April 24, 2017 2:18 pm

Four out of five older Americans with hearing loss just ignore it, in part because a hearing aid is an unwelcome sign of aging. But what if hearing aids looked like stylish fashion accessories and could be bought at your local pharmacy like reading glasses?

That's the vision of Kristen "KR" Liu, who's the director of accessibility and advocacy for Doppler Labs, a company marketing one of these devices. She thinks a hearing aid could be "something that's hip and cool and people have multiple pairs and it's fashionable."

Liu, who has severe hearing loss herself, helped design a device designed to let people with hearing loss blend in. One person may be using the technology to stream music or take a phone call, she says. Another may be wearing it to amplify speech and hear the conversation. "And no one is going to know the difference," Liu says. "So you're wearing technology in your ear, proudly."

The device is a small circular instrument that fits snugly in the ear. It can be adjusted to individual hearing using a smartphone app to control volume, cut out background noise or turn up the sound in a theater. "It's pretty much a hearing aid," says Liu, except the company isn't allowed to call it that.

That's because the Food and Drug Administration, which regulates medical devices, doesn't allow hearing aids to be sold over the counter. So devices sold directly to consumers are marketed as "personal sound amplification products," or PSAPs. They range in price from about $250 to $350 and are considerably cheaper than hearing aids, which can cost up to $6,000 and are typically not covered by Medicare or most private insurance companies. Hearing aids are customized by a hearing specialist such as an audiologist, following a hearing test.

PSAPs can only be marketed as sound amplifiers for people with normal hearing who want to make things louder, like music or the sounds of birds chirping. Hearing loss advocates believe this means people with mild to moderate hearing loss who could benefit from the devices don't know about them. There are dozens of the devices on the market, but their quality varies wildly, as an analysis of 11 of them last year for hearing care professionals shows. And there's no easy way for potential purchasers to figure out which work best.

The Hearing Loss Association of America, a consumer group, wants Congress to create a new category of aids for people with mild to moderate hearing loss by passing the Over-the-Counter Hearing Aid Act of 2017. (People with severe hearing loss would still need to be seen by a medical professional.) The bill would direct the FDA to come up with safety and effectiveness standards for these new hearing aids.

The FDA is already moving in that direction, and in December said it would no longer require adults to be medically evaluated before buying a hearing aid. Proponents of direct-to-consumer sales hope congressional action would get the FDA moving faster. A 2016 report from the National Academies of Sciences also endorsed allowing over-the-counter sales.

Early one morning in 2010, he woke up with his ears ringing — a loud, piercing hiss. "I hit the panic button," Einhorn says. "I jumped out of bed and immediately fell over onto the floor."

An inner ear infection, likely a virus, had caused him to lose his balance. He went deaf in his right ear. He already had some hearing loss in his left ear. His hearing aids cost $5,000 and were not covered by insurance.

"I'm a composer, for goodness sake," Einhorn says. "This is not an easy purchase to scrounge up the money for."

It would also encourage companies to come up with new and better products, says Liu. She envisions a future that solves one of the biggest problems for many people — hearing in a noisy environment, like a party or a busy restaurant. She wants a hearing aid that would automatically adjust to different sound environments, so she could hear the person talking to her and not the background distraction.

"Nothing like that exists today," Liu says. "But I very much see something like that down the road."

Some audio specialists support rolling back regulations, while others are skeptical.

Hearing loss is complex, says Neil DiSarno, chief staff officer for audiology at the American Speech-Language-Hearing Association. This makes it difficult for consumers to "self-evaluate, self-treat and self-monitor," he says. If people buy their hearing aids directly over the counter, they'll miss out on all the skills audiologists can teach them, like how to lip read and how to distinguish high frequency sounds, he says.

The market for over-the-counter hearing aids could be huge. More than 35 million Americans have some degree of hearing loss. And for older Americans, not dealing with the problem can have a big impact on age-related cognitive decline, says Dr. Frank Lin, associate professor of otolaryngology at Johns Hopkins University School of Medicine. Lin has done studies looking at the link between hearing loss and cognitive decline.

"The greater the hearing loss, the greater the risk of loss of thinking and memory abilities over time," he says, which can lead to feelings of insecurity and social isolation — a known risk factor for dementia.

Lin says his findings should serve as a "wake-up call" for policymakers. If people have easier access to more affordable hearing aids, he says, that could lead to benefits that go far beyond hearing.

Copyright 2017 NPR. To see more, visit http://www.npr.org/.

STEVE INSKEEP, HOST:

Some people with hearing loss want to change the rules so they can buy hearing aids over the counter at a local pharmacy. These would be stylish earbuds that can help with mild to moderate hearing problems. Here's NPR's Patti Neighmond.

PATTI NEIGHMOND, BYLINE: Four out of 5 older Americans with hearing loss just ignore it, in part because a hearing aid is an unwelcomed sign of aging. But KR Liu, who has advocated for hearing help for years, says the fix could be as simple as buying stylish reading glasses.

KR LIU: Something that's hip and cool and people have multiple different pairs, and it's fashionable.

NEIGHMOND: Liu, who has severe hearing loss herself, works with a high-tech start-up, Doppler Labs. She helped design a device that will help anyone embarrassed about their hearing loss just blend in.

LIU: And if one person is wearing their technology to, you know, stream music or a phone call to turn down the world and another person is wearing it to amplify speech and hear their conversation, no one is going to know that that's why they're doing that. So you're wearing tech in your year proudly.

NEIGHMOND: It's a little circular device that sits in your ear. It can be adjusted to individual hearing using an app on a smartphone to control volume, cut out background noise or turn up the sound in a theater. It's pretty much a hearing aid, Liu says, except right now, federal regulations prohibit the company from saying that.

LIU: Which is kind of disappointing when, you know, there are people who come to us and say, you know, I want to try your product or I have used your product and have mild to moderate hearing loss, and it's changed my life.

NEIGHMOND: Current rules require a hearing specialist, like an audiologist, test your hearing and customize the hearing aid. It often takes numerous visits and costs thousands of dollars. Richard Einhorn, a well-known composer of modern classical music, knows that well. Seven years ago, he woke up at 5 a.m., his ears ringing with a loud, piercing hiss.

RICHARD EINHORN: Obviously, I hit the panic button, and I jumped out of bed and immediately fell over onto the floor really hard.

NEIGHMOND: Einhorn suffered an inner ear infection that caused him to lose balance. He went deaf in his right ear. His hearing aids cost $5,000 and were not covered by insurance.

EINHORN: I'm a composer, for goodness sakes. This is not an easy purchase to scrounge up the money for.

NEIGHMOND: Einhorn is on the board of the Hearing Loss Association of America, which is pushing Congress to remove the requirement that hearing aids be dispensed only by an audio specialist. People with severe hearing loss would still need to be examined by a medical professional, but people with moderate hearing loss could buy hearing aids over the counter. This could lead to greater use. And that's a good thing, says Dr. Frank Lin, an ear, nose and throat surgeon at Johns Hopkins University. He's done numerous studies about the consequences of not treating hearing loss.

FRANK LIN: We're finding that the greater the hearing loss is actually the greater the risk of loss of thinking and memory abilities over time.

NEIGHMOND: Which often leads to social isolation, a known risk factor for dementia. KR Liu says opening up the market will foster competition, drive prices down and encourage companies to come up with newer and better products. She envisions a future that solves one of the biggest problems, hearing in a noisy environment.

LIU: I would walk into a room, and all I would hear is what I want to hear - right? - is the person talking in front of me in a loud cocktail party. And I don't have a single distraction, and that technology is doing all the work for me. And I can enjoy the conversation. Nothing really exists like that today, but I very much see something like that down the road.

NEIGHMOND: Manufacturers of hearing aids oppose rolling back regulations. So do groups of audio specialists who argue consumers cannot properly customize their own device. But in an era where politicians don't seem to agree on anything, this bill has bipartisan support. Patti Neighmond, NPR News.